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| Name | Class |
|---|---|
| University of Milan | OTHER |
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This study investigates what independent variables may influence Midazolam Pharmacokinetics in critically ill patients.
This study has three specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam | Patients will be enrolled within 24h from the beginning of continuous Midazolam perfusion. Blood and urine sampling will follow this schedule:
Blood samples will be centrifuged for 10 minutes at 3300rpm, then supernatant will be placed into test tubes and stored at -20°C; urine samples will be freeze at -20°C as well. Then all frozen samples will be analyzed to get Midazolam concentrations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and urine sampling | Procedure | Blood and urine sampling will follow this schedule:
Then all frozen samples will be analyzed to get Midazolam concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam concentration in serum and urine | We will calculate Midazolam AUC in serum and urine using blood and urine samples. With this data we will evaluate the elimination constants and create a Physiologically Based Pharmacokinetic Model for Midazolam simulating the drug concentration profile in brain and fat tissue. The blood and urine samples timing is:
| Participants will be followed for the duration of hospital stay, an expected average of 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fat mass analysis and its importance in drug distribution. | At enrollment we will collect data about fat mass in our population. Our goal is to determine how much this variable can modify the distribution of Midazolam in the body. Statistical analysis will performed to found if different body mass values are correlated with different blood concentration of Midazolam at steady level. | At enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill patients in Intensive Care Unit, mechanically ventilated, sedated with midazolam, intravenous continued perfusion.
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Severgnini, Prof. | Università degli Studi dell'Insubria, Varese, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D003128 | Coma |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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serum and urine
|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |